The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xolair® (omalizumab; Genentech and Novartis) prefilled syringe for self-injection across all indications for appropriate patients.

Xolair, an anti-immunoglobulin E antibody, is indicated for the treatment of moderate to severe persistent asthma, chronic idiopathic urticaria, and nasal polyps. The prefilled syringe can now be used for subcutaneous (SC) self-administration outside of a healthcare setting in select patients as determined by a healthcare professional (HCP). Patient-specific factors to establish appropriateness include the following:

  • No prior history of anaphylaxis with Xolair or other agents (ie, foods, drugs, biologics).
  • At least 3 doses of Xolair have been received under the guidance of an HCP with no hypersensitivity reactions.
  • Patient or caregiver is able to recognize anaphylaxis symptoms and is able to treat appropriately.
  • Patient or caregiver is able to properly prepare and administer subcutaneous injections with Xolair prefilled syringe following training with an HCP.

“With the new offering of self-injection for Xolair, healthcare providers now have an additional administration option for appropriate patients, which is particularly timely given the COVID-19 pandemic,” said Victor Bultó, President, Novartis Pharmaceuticals Corporation.

Xolair prefilled syringe is supplied in 75mg/0.5mL and 150mg/mL strengths.


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References

  1. Novartis receives FDA approval of Xolair® (omalizumab) self-injection with prefilled syringe across all indications for appropriate patients. [press release]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 12, 2021. 
  2. Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; 2021.